Registration of biocidal products

We offer a registration service for biocidal products at the Office for Registration of Medicines, Medical Devices and Biocidal Products. The offer includes registration in both national and European procedures. We help in completing the documentation. We provide all necessary laboratory tests before implementation. By registering your product through us, you save time and money.

Registration of biocidal products in the national procedure

Registration under the national procedure applies to products that contain existing active substances assessed or under evaluation under Regulation No 1062/2014, of which at least one active substance has not yet been approved for a given product group

A marketing authorization may be issued if the following conditions are met:

  1. the product meets the definition of a biocidal product contained in Art. 3 section 1 letter a of Regulation No. 528/2012;
  2. the biocidal product contains existing active substances assessed or under evaluation under Regulation No. 1062/2014  but which have not been approved for this product group;
  3. the biocidal product is effective in combating the harmful organism;
  4. safety rules for the use of a biocidal product have been defined;
  5. the intended use of the product should be included in the categories and groups contained in Annex V to Regulation No. 528/2012;
  6. and the supplier of the active substance (or biocidal product) should meet the requirements referred to in Art. 95 of Regulation No. 528/2012.

The marketing authorization specifies:

  1. name of the biocidal product;
  2. marketing authorization number and date of issue and validity period;
  3. name and surname and address or name (company) and registered office address of the responsible entity;
  4. name and surname and address or name (company) and address of the registered office of the manufacturer of the biocidal product;
  5. the chemical name of the active substance or substances or any other name enabling the identity of the active substance to be established and, if a CAS number is available, its content in the biocidal product in metric units;
  6. product group;
  7. formulation of the biocidal product and its intended use;
  8. information about the type of user;
  9. a kind of package;
  10. shelf life of the biocidal product;
  11. content of the labeling of the biocidal product packaging in Polish

Registration of biocidal products under the European procedure

Registration of biocidal products according to the so-called European procedures are carried out in accordance with the principles described in detail in Regulation No. 528/2012, which applies in the EU from 1 September 2013.

European procedures apply to biocidal products whose active substances have all been:

  1. approved in a given product group (PT), i.e. they have passed a positive assessment in the review program or
  2. are included in Annex I to Regulation No. 528/2012, i.e. they are active substances with a low risk to human health and the environment

For products containing approved active substances, the following registration procedures are possible:

  1. procedure leading to the issuance of a national permit valid in Poland

– mutual sequential recognition (MRS) of a permit issued in another EU country – a procedure leading to the issuance of a national permit valid in Poland

– parallel mutual recognition (MRP) of a permit issued in another EU country – a procedure leading to the issuance of a national permit valid in Poland

  • procedure leading to the issuance of a parallel trade permit, valid in Poland
  • a procedure leading to the issuance of an EU permit, valid in all EU countries

For products containing active substances listed in Annex I to Regulation No. 528/2012, registration takes place:

– in accordance with a simplified procedure leading to the issuance of a permit that may be valid in any EU country after prior notification of this permit in a given country.

Regarding the offer of registration of biocidal products, please contact the Customer Service Office at: 22 379 25 20 or biuro@ekolabos.pl